CLA-2 CO:R:C:F 088196 SLR

Kathleen M. Murphy, Esq.
Katten, Muchin & Zavis
525 West Monroe Street
Suite 1600
Chicago, IL 60606-3693

RE: Blood Diagnostic Test Strips; Composite Diagnostic or Laboratory Reagents of Heading 3822, HTSUSA; Composite Diagnostic or Laboratory Reagents Containing Antigens or Antisera of Subheading 3822.00.10, HTSUSA. Dear Ms. Murphy:

This is in response to your letter of November 6, 1990, written on behalf of your client, MediSense, Inc., requesting the classification of certain glucose test strips under the Harmonized Tariff Schedule of the United States Annotated (HTSUSA). A sample was submitted for our examination.

FACTS:

The merchandise at issue consists of glucose test strips designed for use with the MediSense Exactech Blood Glucose Monitoring System. Diabetics use the system to monitor their blood glucose levels.

The test strips are made of plastic and contain glucose oxidase, along with other ingredients which are proprietary. Each test strip has a target area whereupon droplets of human blood combine with the glucose oxidase and the other ingredients to produce electrical microcurrents. The ExacTech Meter measures these currents and displays a digital read-out of the user's glucose level.

In your letter, you posit that the merchandise in question is classifiable in heading 3822, HTSUSA, the provision for diagnostic or laboratory reagents other than those of heading 3002 or 3006. Furthermore, you maintain that the test strips are classifiable in subheading 3822.00.10, HTSUSA, the provision for diagnostic or laboratory reagents other than those of heading 3002 or 3006, containing antigens or antisera. You insist that glucose oxidase qualifies as an antigen. -2-

You and several of your colleagues have met with Customs Headquarters personnel to discuss the instant case. You have since forwarded numerous submissions containing information designed to bolster your position that glucose oxidase is an antigen.

ISSUE:

What is the proper classification of the glucose test strips under the HTSUSA? LAW AND ANALYSIS:

Customs agrees that the glucose test strips are classifiable in heading 3822, HTSUSA, the provision for composite diagnostic or laboratory reagents. The question is whether the test strips contain "antigens" for the purposes of subheading 3822.00.10, HTSUSA.

Subheading 3822.00.10, HTSUSA, provides, in pertinent part, for composite diagnostic or laboratory reagents containing antigens. Neither the Harmonized Tariff Schedule nor the Explanatory Notes offers guidance in what constitutes an "antigen" for tariff purposes. As a result, reference must be made to dictionaries and other lexicographic sources.

According to Taber's Cyclopedic Medical Dictionary, (13th ed. 1979), at p. A-97, an antigen is a substance which induces the formation of antibodies. Taber's defines "antibodies" as protein substances developed by the body, usually in response to the presence of an antigen which has been administered parenterally or has otherwise gained access to the body.

Customs has not been persuaded that glucose oxidase is an antigen. Nonetheless, your most recent submission has provided Customs with information regarding the reactive qualities of the test strips' other ingredients; and, on this basis, we acknowledge the presence of an antigen on the test strips. Accordingly, the test strips are classificable in subheading 3822.00.10, HTSUSA. HOLDING:

The glucose test strips are classifiable in subheading 3822.00.1090, HTSUSA, which provides for composite diagnostic or laboratory reagents, other than those of heading 3002 or 3006: Containing antigens or antisera, other (than containing methyl chloroform (1,1,1-trichloromethane) or carbon tetrachloride).

-3-

Merchandise classifiable in subheading 3822.00.1090, HTSUSA, may enter the United States duty free.


Sincerely,

John Durant, Director
Commercial Rulings Division